ISO 14155:2020 - Scope
This course covers the background of the ISO 14155 standard and how it applies in conjunction with international regulatory documents. It outlines the scope of the ISO 14155 and how it’s requirements apply to the different types of medical clinical investigations.
The course provides a summary of GCP principles as outlined in the standard and provides a list of documents referenced in the standard.
This course also explores other mandatory standards needed to conduct clinical investigations such as ISO 14971.
Upon successfully completing this course, learners will be able to:
- Know when to apply ISO 14155requirements
- Use ISO 14155 in conjunction with other international regulatory documents
- Decide whether or not to exempt certain requirements from ISO 14155 for post-market clinical investigations
- Use other standard requirements and guidance documents together with ISO 14155
- Understand the general GCP requirements as further elaborated throughout the ISO 14155.
Clinical research associates (monitors), clinical study coordinators, assistant senior clinical research associates, clinical project and data managers, data entry personnel, ethics committee and institutional review board members, regulators, and notified body personnel involved in auditing clinical evaluations are all welcome to participate in this course.
The following courses are required:
For Investigation site personnel
- Medical Device GCP for Investigators (series; IDs 193, 200, 212, 202, 204, 206)
For Sponsor personnel
- History of Good Clinical Practice (GCP) (ID 41)
- Introduction to Good Clinical Practice (ID 42)
- Introduction to Medical Device and Clinical Investigation Planning (ID 43)